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HealthyPhase 1NCT06111521

A Drug-Drug Interaction Study of LY3537982 on Midazolam, Digoxin, and Rosuvastatin in Healthy Participants

A Phase 1 study testing LY3537982, Digoxin and Rosuvastatin in people with Healthy, run by Eli Lilly and Company at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The main purpose of this study is to evaluate the effects of multiple doses of LY3537982 on the pharmacokinetics (PK) of digoxin (a P-glycoprotein [P-gp] substrate), rosuvastatin (a breast cancer resistance protein [BCRP)] substrate), and midazolam (a substrate of Cytochrome P450 3A4 [CYP3A4]) in adult healthy… Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
LY3537982, Digoxin and Rosuvastatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteUnited States
Study dates
27 Oct 2023to 1 Apr 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy status as defined by the absence of evidence of any clinically significant active or chronic disease
  • Body mass index (BMI): 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive

Who cannot join

  • Females who are lactating or of childbearing potential
  • Clinically significant history of any drug sensitivity, drug allergy, or food allergy

Trial locations and contacts

1 site in 1 country.

United States1 site

  • ICON Early Clinical & Bioanalytical Solutions

    Salt Lake City, Utah, 84124

Other trials in United States

About this study

Official title: A PHASE 1 STUDY TO EVALUATE THE EFFECTS OF MULTIPLE DOSES OF LY3537982 ON THE SINGLE-DOSE PHARMACOKINETICS OF MIDAZOLAM, DIGOXIN, AND ROSUVASTATIN IN HEALTHY ADULT SUBJECTS

The main purpose of this study is to evaluate the effects of multiple doses of LY3537982 on the pharmacokinetics (PK) of digoxin (a P-glycoprotein [P-gp] substrate), rosuvastatin (a breast cancer resistance protein [BCRP)] substrate), and midazolam (a substrate of Cytochrome P450 3A4 [CYP3A4]) in adult healthy participants. The study will also evaluate the safety and tolerability of LY3537982 with or without single doses of digoxin, rosuvastatin, and midazolam. The study is conducted in two parts. Participants will stay in the research center during the study, which will last about 23 and 11 days for part 1 and part 2, respectively, not including screening.

Conditions
Healthy
Being tested
LY3537982, Digoxin, Rosuvastatin, Midazolam

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LY3537982Drug

    Also called Olomorasib

    Administered orally

  • DigoxinDrug

    Administered orally

  • RosuvastatinDrug

    Administered orally

  • MidazolamDrug

    Administered orally

  • MidazolamDrug

    Administered IV

Study groups in NCT06111521
Study groupRoleWhat they receive
LY3537982 + Digoxin & Rosuvastatin (Part 1)ExperimentalSingle oral doses of digoxin and rosuvastatin with or without multiple doses of LY3537982 administered orally
Receives: Drug: LY3537982; Drug: Digoxin; Drug: Rosuvastatin
LY3537982 + Midazolam (Part 2)ExperimentalSingle doses of midazolam administered either orally or intravenously (IV) with or without multiple doses of LY3537982 administered orally
Receives: Drug: LY3537982; Drug: Midazolam

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1: Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3537982

    Part 1: PK: Cmax of LY3537982

    Measured: Predose on day 11 up to day 17

  2. Part 1: PK: Area Under the Concentration-Time Curve (AUC) from Time 0 to Infinity (AUC[0-inf]) of LY3537982

    Part 1: PK: AUC[0-inf] of LY3537982

    Measured: Predose on day 11 up to day 17

  3. Part 1: PK: AUC from Time 0 to time of the last measurable concentration (AUClast) of LY3537982

    Part 1: PK: AUClast of LY3537982

    Measured: Predose on day 11 up to day 17

  4. Part 1: PK: Cmax of Digoxin

    Part 1: PK: Cmax of Digoxin

    Measured: Predose on day 1 up to day 21

  5. Part 1: PK: AUC[0-inf] of Digoxin

    Part 1: PK: AUC[0-inf] of Digoxin

    Measured: Predose on day 1 up to day 21

  6. Part 1: PK: AUClast of Digoxin

    Part 1: PK: AUClast of Digoxin

    Measured: Predose on day 1 up to day 21

  7. Part 1: PK: Cmax of Rosuvastatin

    Part 1: PK: Cmax of Rosuvastatin

    Measured: Predose on day 1 up to day 21

  8. Part 1: PK: AUC[0-inf] of Rosuvastatin

    Part 1: PK: AUC[0-inf] of Rosuvastatin

    Measured: Predose on day 1 up to day 21

  9. Part 1: PK: AUClast of Rosuvastatin

    Part 1: PK: AUClast of Rosuvastatin

    Measured: Predose on day 1 up to day 21

  10. Part 2: PK: Cmax of LY3537982

    Part 2: PK: Cmax of LY3537982

    Measured: Predose on day 4 up to day 11

  11. Part 2: PK: AUC[0-inf] of LY3537982

    Part 2: PK: AUC[0-inf] of LY3537982

    Measured: Predose on day 4 up to day 11

  12. Part 2: PK: AUClast of LY3537982

    Part 2: PK: AUClast of LY3537982

    Measured: Predose on day 4 up to day 11

  13. Part 2: PK: Cmax of Midazolam

    Part 2: PK: Cmax of Midazolam

    Measured: Predose on day 1 up to day 9

  14. Part 2: PK: AUC[0-inf] of Midazolam

    Part 2: PK: AUC[0-inf] of Midazolam

    Measured: Predose on day 1 up to day 9

  15. Part 2: PK: AUClast of Midazolam

    Part 2: PK: AUClast of Midazolam

    Measured: Predose on day 1 up to day 9

  16. Part 2: PK: Cmax of 1'-Hydroxymidazolam

    Part 2: PK: Cmax of 1'-Hydroxymidazolam

    Measured: Predose on day 1 up to day 9

  17. Part 2: PK: AUC[0-inf] of 1'-Hydroxymidazolam

    Part 2: PK: AUC[0-inf] of 1'-Hydroxymidazolam

    Measured: Predose on day 1 up to day 9

  18. Part 2: PK: AUClast of 1'-Hydroxymidazolam

    Part 2: PK: AUClast of 1'-Hydroxymidazolam

    Measured: Predose on day 1 up to day 9

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 2023
  2. Study start27 Oct 2023
  3. Primary completion1 Apr 2024
  4. Study completion1 Apr 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06111521
Sponsor's protocol ID
LOXO-RAS-23007
Other IDs
J3M-OX-JZQJ
Status last verified
Nov 2024
First submitted
27 Oct 2023
Last updated
8 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LY3537982, Digoxin and Rosuvastatin in people with Healthy, run by Eli Lilly and Company at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1: Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3537982 (time frame: Predose on day 11 up to day 17). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06111521.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2024; AzTrials last refreshed its copy on 8 Nov 2026.

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